NCT05651867

Brief Summary

Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 28, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

July 15, 2025

Completed
Last Updated

July 15, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

November 28, 2022

Results QC Date

May 7, 2025

Last Update Submit

June 25, 2025

Conditions

Lung Cancer

Keywords

percutaneousCT-guidedAblationBiopsyAbcess DrainageFiducial placementLungRobotics

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the Device

    Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.

    an average of 7 months

Secondary Outcomes (6)

  • Needle Placement Accuracy

    an average of 7 months

  • Number of Needle Adjustments

    an average of 7 months

  • Post-intervention Ablation Success

    an average of 1 year

  • Long-term Efficacy of Ablation

    through study completion, an average of 1 year

  • Adverse Event

    through study completion, an average of 21 months

  • +1 more secondary outcomes

Study Arms (1)

Interventional arm

EXPERIMENTAL

Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device

Device: EPIONE device

Interventions

EPIONE deviceDEVICE

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

Interventional arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient ≥18 years old,
  • Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
  • Patient with a signed informed consent form.
  • Patient covered by a social security system.

You may not qualify if:

  • Patient unable to undergo general anesthesia,
  • Pregnant or nursing female, confirmed before the intervention
  • Patient already participating in another clinical study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Institut

Villejuif, 94000, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Marion Chassouant
Organization
Quantum Surgical
m.chassouant@quantumsurgical.com
0033781425198

Study Officials

  • Baptiste BONNET, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 15, 2022

Study Start

November 28, 2022

Primary Completion

August 25, 2023

Study Completion

September 10, 2024

Last Updated

July 15, 2025

Results First Posted

July 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)